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Transcranial Magnetic Stimulation (TMS) Effects on Pain Perception

Primary Purpose

Pain, Trigeminal Neuralgia, Neuropathic Pain

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
laboratory pain assessment
transcranial magnetic stimulation
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring trigeminal neuralgia, neuropathic pain, complex regional pain syndrome, reflex sympathetic dystrophy, pain, chronic pain, transcranial magnetic stimulation, TMS, laboratory pain assessment

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: For Healthy Adults: Between age of 21 and 60 No prescription medications in previous 3 months No seizure history No depression Not suicidal No anxiety No hospitalizations or surgeries in previous 6 months No history of chronic pain conditions No implanted metal devices (e.g., pacemakers, metal plates, wires) Not pregnant No alcohol abuse/dependence history in previous 6 months No illicit drug use in previous 6 months Capable of reading, writing, giving consent, following instructions No history of brain surgery or history of loss of consciousness >15 minutes No history of autoimmune or endocrine disorder No significant anxiety about entering MRI scanner For Patients with neuropathic pain: Between age of 21 and 75 No seizure history Not taking medications shown to increase seizure risk (6 months) Not suicidal No hospitalizations or surgeries in previous 3 months No implanted metal devices (e.g., pacemakers, metal plates, wires) Not pregnant No alcohol abuse/dependence history in previous 6 months No illicit drug use in previous 6 months Capable of reading, writing, giving consent, following instructions Chronic pain (>6 months), not significantly relieved by pharmacological treatment No significant anxiety about entering MRI scanner

Sites / Locations

  • Brain Stimulation Laboratory, Department of Psychiatry and Behavioral Sciences Medical University of South Carolina 5-North, IOP, 67 President Street

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

laboratory pain assessment

transcranial magnetic stimulation

Outcomes

Primary Outcome Measures

Clinical neuropathic pain ratings, activity levels, analgesic medication usage, mood ratings, laboratory pain measures (thermal and mechanical pain thresholds, suprathreshold pain ratings, and wind-up pain ratings).

Secondary Outcome Measures

Full Information

First Posted
July 5, 2006
Last Updated
April 26, 2012
Sponsor
Medical University of South Carolina
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00349050
Brief Title
Transcranial Magnetic Stimulation (TMS) Effects on Pain Perception
Official Title
Transcranial Magnetic Stimulation (TMS) Effects on Pain Perception
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Withdrawn
Study Start Date
July 2006 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to investigate the effects of transcranial magnetic stimulation on pain perception.
Detailed Description
Chronic pain represents a huge public health concern and is generally poorly understood at a basic neurobiological level. Transcranial magnetic stimulation (TMS) is a non-invasive technique that uses electromagnetic pulses to temporarily stimulate specific brain areas in awake people (without the need for surgery, anesthesia, or other invasive procedures). Previous research suggests that TMS may be effective in reducing pain perception in healthy adults and in patients with various types of pain conditions, such as neuropathic pain. However, there is relatively little research on TMS and pain that addresses optimal TMS device parameters, optimal cortical targets, and potential differences in response to TMS between healthy persons and those with chronic pain. The purpose of this trial is to study the effects of TMS on pain perception. Specifically, this study will determine optimal device parameters (dose) and brain targets for stimulation with TMS in order to reduce pain in patients with neuropathic pain and in healthy adults using laboratory pain methods. Participants with Neuropathic Pain: After an initial screening, eligible participants with neuropathic pain will receive a magnetic resonance imaging (MRI) scan to help determine the best target for TMS stimulation later in the study. Participants will be asked to record their pain experiences every day for 2-4 weeks before receiving the first of 2 laboratory pain assessments. The laboratory pain assessment uses a small device, controlled by a computer and attached to the underside of the forearm, to produce different temperature stimulations. As the device reaches a level considered painful to the participant, he/she can push a button to return to a level of comfort. The next part of the trial involves two, 20-minute TMS treatment sessions per day for 5-days. Participants will be randomly assigned to one of two groups. Group A will receive real TMS and Group B will receive "sham" TMS. Study participation time for individuals with TGN is about 8 weeks, including about 10 hours (7 visits) at the Medical University of South Carolina (MUSC). Healthy Volunteers: In addition to an interview with researchers regarding medical history, healthy participants will complete a self-report screening to assess pain history and level of depression and anxiety. Eligible participants will be given a laboratory pain assessment, and be randomly assigned to one of two groups: group A will receive real TMS and group B will receive "sham" TMS. After TMS, participants will receive another full laboratory pain assessment and complete questionnaires. For healthy volunteers, participation in the study will take about 3 hours and may be completed in one or two visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Trigeminal Neuralgia, Neuropathic Pain
Keywords
trigeminal neuralgia, neuropathic pain, complex regional pain syndrome, reflex sympathetic dystrophy, pain, chronic pain, transcranial magnetic stimulation, TMS, laboratory pain assessment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
laboratory pain assessment
Arm Title
2
Arm Type
Active Comparator
Arm Description
transcranial magnetic stimulation
Intervention Type
Device
Intervention Name(s)
laboratory pain assessment
Intervention Description
Participants will record their pain experiences every day for 2 weeks before receiving the first of 5 laboratory pain assessments. The laboratory pain assessment uses a small device, controlled by a computer and attached to the underside of the forearm, to produce different temperature stimulations. As the device reaches a level considered painful to the participant, he/she can push a button to return to a level of comfort.
Intervention Type
Procedure
Intervention Name(s)
transcranial magnetic stimulation
Intervention Description
There will be two, 20-minute, 3-day TMS treatment sessions. Participants will be randomly assigned to one of two groups. Group A will receive real TMS for the first 3-day treatment and "sham" TMS (which does not involve real stimulation) for the second treatment. Group B will receive "sham" TMS for the first treatment, and real TMS for the second treatment. Regardless of the group, participants will receive both real and "sham" TMS.
Primary Outcome Measure Information:
Title
Clinical neuropathic pain ratings, activity levels, analgesic medication usage, mood ratings, laboratory pain measures (thermal and mechanical pain thresholds, suprathreshold pain ratings, and wind-up pain ratings).
Time Frame
measured during the study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: For Healthy Adults: Between age of 21 and 60 No prescription medications in previous 3 months No seizure history No depression Not suicidal No anxiety No hospitalizations or surgeries in previous 6 months No history of chronic pain conditions No implanted metal devices (e.g., pacemakers, metal plates, wires) Not pregnant No alcohol abuse/dependence history in previous 6 months No illicit drug use in previous 6 months Capable of reading, writing, giving consent, following instructions No history of brain surgery or history of loss of consciousness >15 minutes No history of autoimmune or endocrine disorder No significant anxiety about entering MRI scanner For Patients with neuropathic pain: Between age of 21 and 75 No seizure history Not taking medications shown to increase seizure risk (6 months) Not suicidal No hospitalizations or surgeries in previous 3 months No implanted metal devices (e.g., pacemakers, metal plates, wires) Not pregnant No alcohol abuse/dependence history in previous 6 months No illicit drug use in previous 6 months Capable of reading, writing, giving consent, following instructions Chronic pain (>6 months), not significantly relieved by pharmacological treatment No significant anxiety about entering MRI scanner
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey J. Borckardt, Ph.D.
Organizational Affiliation
Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brain Stimulation Laboratory, Department of Psychiatry and Behavioral Sciences Medical University of South Carolina 5-North, IOP, 67 President Street
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

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Transcranial Magnetic Stimulation (TMS) Effects on Pain Perception

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